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Proton Pump Inhibitor

Gene-Tailored Acid Reflux Medication for Children with Asthma (GenARA Trial)

Phase 3
Waitlist Available
Led By Jason E Lang, MD, MPH
Research Sponsored by Jason Lang, M.D., M.P.H.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age: 6-17 year olds with documented clinician-diagnosed asthma
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at weeks -2 (screening), 0 (baseline), 4, 8, 12,16, 20, 26
Awards & highlights

GenARA Trial Summary

This trial will see if lansoprazole works better for children with GER and uncontrolled asthma when the dose is based on their CYP2C19 and ABCB1 genes.

Who is the study for?
This trial is for children aged 6-17 with asthma and mild acid reflux. They must have uncontrolled asthma, be on a stable dose of inhaled corticosteroids, and not have severe GERD or other major illnesses that could affect the study. Kids can't join if they've had certain treatments or conditions like intubation for asthma, use specific medications that interact with the study drug, or have allergies to lansoprazole.Check my eligibility
What is being tested?
The trial tests whether adjusting doses of lansoprazole based on kids' genes (CYP2C19 and ABCB1) helps control acid reflux and improves their asthma. It compares this tailored treatment against a placebo to see which works better.See study design
What are the potential side effects?
Lansoprazole may cause headaches, stomach pain, diarrhea or constipation, nausea/vomiting, fatigue. Rarely it might lead to more serious issues like vitamin deficiencies or bone fractures.

GenARA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Children and teenagers between 6 and 17 years old who have been diagnosed with asthma by a doctor.

GenARA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at weeks -2 (screening), 0 (baseline), 4, 8, 12,16, 20, 26
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at weeks -2 (screening), 0 (baseline), 4, 8, 12,16, 20, 26 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Asthma Control Questionnaire (ACQ) from Screening through Week 26
Secondary outcome measures
Annualized rate of Episodes of Poor Asthma Control (EPAC)
Annualized rate of asthma exacerbations
Annualized rate of respiratory tract infection (RTI)
+3 more

GenARA Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Genotype-guided LansoprazoleExperimental Treatment1 Intervention
participants will receive oral blinded commercially available lansoprazole once daily with a dose appropriate for the participant's metabolizer phenotype
Group II: PlaceboPlacebo Group1 Intervention
participants will receive oral blinded matched placebo once daily

Find a Location

Who is running the clinical trial?

Nemours Children's ClinicOTHER
124 Previous Clinical Trials
18,082 Total Patients Enrolled
13 Trials studying Asthma
971 Patients Enrolled for Asthma
Jason Lang, M.D., M.P.H.Lead Sponsor
Thrasher Research FundOTHER
132 Previous Clinical Trials
94,333 Total Patients Enrolled
1 Trials studying Asthma
26 Patients Enrolled for Asthma

Media Library

Lansoprazole (Proton Pump Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03015610 — Phase 3
Asthma Clinical Trial 2023: Lansoprazole Highlights & Side Effects. Trial Name: NCT03015610 — Phase 3
Asthma Research Study Groups: Placebo, Genotype-guided Lansoprazole
Lansoprazole (Proton Pump Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03015610 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any comparable studies to this one that use lansoprazole?

"The medication lansoprazole was first studied in 2010 at National Taiwan University Hospital. In the decade since, there have been a total of 118 completed clinical trials performed across the world. Currently, there are 7 active trials taking place, with several of these happening in Durham, North carolina."

Answered by AI

What is lansoprazole's primary use?

"Lansoprazole, which is available for purchase without a prescription, is most often taken to treat zollinger-ellison syndrome. However, it can also be used as medication for other conditions such as nsaid use and gastric ulcers associated with nsaids or erosive esophagitis."

Answered by AI

Are there any preconditions for participating in this research project?

"Researchers conducting this study are looking for children aged 6 to 17 that have been diagnosed with asthma. They hope to enroll a total of 110 patients."

Answered by AI

Has the lansoprazole medication been cleared by the FDA for consumer use?

"This medication has been commercially available for some time and, as such, has received a score of 3 on the Power team's safety scale."

Answered by AI

Are there any available openings for individuals in this clinical trial?

"That is correct. The clinical trial was posted on 2017-10-31 and is currently recruiting for 110 patients from 2 locations, as indicated by the most recent edit made on 2022-05-25."

Answered by AI

Does this experiment test the effects of the medication on elderly patients?

"In order to participate in this trial, patients must be between 6 and 17 years old. Out of the 396 total clinical trials, 132 are for pediatric patients and 264 are for geriatric patients."

Answered by AI

How many individuals are included in this clinical trial?

"Yes, this is an ongoing medical trial that was first announced on October 31st, 2017. The most recent update to the study was on May 25th, 2022. They are looking for a total of 110 volunteers from 2 different locations."

Answered by AI
~6 spots leftby Mar 2025